NCT01516944已完成2 期
Perioperative Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin in Patients With Localized Advanced Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 749
- 试验地点
- 1
- 主要终点
- Disease-free survival(DFS)
研究概览
简要总结
Stage I：Neoadjuvant therapy
- Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin
Stage II: Perioperative therapy
- Perioperative Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to adjuvant Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin alone;Capecitabine plus oxaliplatin regimen is noninferiority to Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin
- A regimen of Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin(SOX) and Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic gastric cancer. The investigators assessed whether the addition of a perioperative regimen of SOX or XELOX regimen to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 -75
- •Histologically or cytologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction)
- •ECOG performance status ≦2
- •Tumor stage T3/4NxM0
- •No distant metastasis (M0)
排除标准
- •History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
- •Inadequate hematopoietic function： WBC≦4,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3
- •Inadequate organ function which is defined as below:
- •Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 1.2 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);
- •Symptomatic peripheral neuropathy
- •Receiving a concomitant treatment with other fluoropyrimidines
- •Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method.
- •Mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication:
- •Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.
- •History of ventricular arrhythmia or congestive heart failure.
- •Significant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary fibrosis, heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes.
研究组 & 干预措施
postoperative chemotherapy,SOX
Active Comparator
干预措施: Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin (Drug)
Perioperative chemotherapy,SOX
Experimental
干预措施: Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin (Drug)
Perioperative chemotherapy,XELOX
Experimental
干预措施: Oxaliplatin; Capecitabine (Drug)
结局指标
主要结局
Disease-free survival(DFS)
时间窗: 3 year
次要结局
- Disease control rate (DCR)(At the end of the study)
- Objective response rate (ORR)(At the end of the study)
- Down staging rate(Within 3 weeks after surgery)
- Overall survival (OS)(5 year)
- Adverse events(Side effects during observation)
- R0-resection rate(Within 3 weeks after surgery)
研究者
Qun Zhao
Principal Investigator
Hebei Medical University
研究点 (1)
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